REG - Immupharma PLC - Lupuzor™ Update

ImmuPharmaAnnouncement

27/03/2023 07:00

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RNS Number : 2290U  Immupharma PLC  27 March 2023

 
27 March 2023

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

Avion submits clinical protocol of Phase 2/3 adaptive study of Lupuzor™ in
lupus to FDA

 

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development
company, is delighted to update the market on the next positive step in its
Lupuzor™ (P140) program in patients with systemic lupus erythematosus
("SLE/Lupus"). This follows on from the recent announcement on 6 February
2023.

 

Key highlights:

 

·    Avion Pharmaceuticals ("Avion") and ImmuPharma agreed in February on
a Phase 2/3 adaptive trial design for the next clinical study of Lupuzor™ in
Lupus patients.

·    A Phase 2/3 clinical trial protocol has now been submitted to the
Food and Drug Administration ("FDA"). This new design takes into account the
FDA's key guidance points from the previous Type-C meeting in addition to
insights from the pharmacokinetic ("PK") study completed last year.

·    The submitted protocol contains many changes from the design of the
previous Phase 3 clinical trial carried out by ImmuPharma. The most
significant and important changes concern the level of dose being administered
and the method of administration.

·    A Type C meeting with the FDA has been requested and the date of the
meeting should be confirmed within the FDA guidelines of 21 days from
submission which is expected to be within the FDA guidelines of 75 days from
submission. We will update the market with the date of the meeting once
confirmed by FDA.

·    The Phase 2/3 study remains on track to commence in H2 2023.

 

On 6 February 2023, ImmuPharma confirmed that they had agreed with Avion on an
adaptive Phase 2/3 study for Lupuzor™ in SLE patients. For background, this
is a one-protocol pivotal study which allows exploration of a dose-range in
the Phase 2 part of the study, followed by seamless progression into the Phase
3 part of the study at the chosen dose. The overall timelines are much shorter
than carrying out two separate protocols (i.e. Phase 2 followed by Phase 3).
It is also expected to be less costly overall.

 

This new study design incorporates guidance from the FDA which advised
exploration of higher dose levels than have been used in the clinical program
to date, and insights gained from data generated  from the PK study completed
last year.

 

Consequently, it is expected that the Phase 2 part of the new clinical trial
will identify a multiple times higher dose level to be used in the Phase 3
part compared to the 200mcg dose given to patients in the previous Phase 3
clinical trial carried out by ImmuPharma. Also it is proposed that the method
of administration will be changed from a subcutaneous injection to an
intravenous injection, so ensuring   that significantly higher blood levels
of Lupuzor™ (P140) can be achieved, thereby greatly increasing the
probability of a significant efficacy result in patients.

 

Importantly, a clean safety profile of Lupuzor™ has already been established
at the higher doses to be examined in the Phase 2 part, thereby preserving the
Target Product Profile of Lupuzor™ which is to be significantly efficacious
for patients with no serious side effects.

 

Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma, said:

 

"We are extremely pleased to be moving positively forward with the Lupuzor™
program. Avion and ourselves believe that the new design of the Phase 2/3
adaptive study offers the greatest probability of a successful result for the
overall benefit of Lupus patients. We remain on track to commence the trial in
H2 2023."

 

Commenting further, Art Deas, CEO of Avion said:

 

"We remain committed to our full support of ImmuPharma, and with insights
gained from last year's PK study and invaluable guidance from the FDA, we
believe we have submitted the most robust clinical protocol for Lupuzor™."

 

This announcement contains inside information as stipulated under the UK
version of the Market Abuse Regulation no 596/2014 which is part of English
law by virtue of the European (withdrawal) Act 2018, as amended.  On
publication of this announcement via a regulatory information service, this
information is considered to be in the public domain.

Ends

 

 For further information please contact:

ImmuPharma PLC (www.immupharma.com (http://www.immupharma.com) )  +44 (0) 207 206 2650

 Tim McCarthy, Chief Executive Officer

 Lisa Baderoon, Head of Investor Relations                         + 44 (0) 7721 413496

 SPARK Advisory Partners Limited (NOMAD)                           +44 (0) 203 368 3550

 Neil Baldwin

 Stanford Capital Partners (Joint Broker)                          +44 (0) 203 650 3650

 Patrick Claridge, John Howes, Bob Pountney

 SI Capital (Joint Broker)                                         +44 (0) 1483 413500

 Nick Emerson

 

Notes to Editors

 

About ImmuPharma PLC

ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical company that
discovers and develops peptide-based therapeutics. The Company's portfolio
includes novel peptide therapeutics for autoimmune diseases and
anti-infectives. The lead program, P140 (Lupuzor™), is a first-in class
autophagy immunomodulator for the treatment of Lupus and preclinical analysis
suggest therapeutic activity for many other autoimmune diseases that share the
same autophagy mechanism of action.

 

For additional information about ImmuPharma please visit www.immupharma
(http://www.immupharma) .co.uk

 

About Avion Pharmaceuticals LLC

Avion Pharmaceuticals, LLC, is a specialty pharmaceutical company formed to
develop, acquire and market a portfolio of innovative pharmaceutical products
in the Women's Health and other therapeutic categories aligned with its
mission to improve the quality of patient lives. Avion Pharmaceuticals focuses
on identifying opportunities to develop, acquire and enhance the market
potential of innovative, commercially available therapeutics and late-stage
development drugs to fulfil unmet medical needs.

For more information, visit www.avionrx.com (https://www.avionrx.com/) .

 

About Lupus (Systemic Lupus Erythematosus / SLE)

 

Lupus is a chronic inflammatory disease which is thought to affect some 5
million individuals worldwide. The current standard of care still consists of
steroid and anti-malarial therapies which many have side-effects and poor
response in many patients. Recently more targeted monoclonal therapies are
GlaxoSmithKline's Benlysta and more recently, AstraZeneca's Saphnelo. There
still exists a high unmet medical need for a drug that has a strong efficacy
and safety profile.

 

 

 

ImmuPharma's LEI (Legal Entity Identifier) code : 213800VZKGHXC7VUS895.

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